Customer Support; Intended Use; Important Safety Information; Manuel D'utilisation Du Surmatelas Roho Sofflex - Permobil ROHO SOFFLEX 2 Operation Manual

Intended Use

The ROHO SOFFLEX 2 Mattress Overlay System (SOFFLEX 2) is a non-powered, air-filled, adjustable, zoned, reactive, full support surface that is intended
to conform to an individual's shape to provide skin/soft tissue and deep tissue injury protection and an environment to facilitate wound healing. The SOFFLEX
2 must be used on top of a standard hospital, nursing home, home care or consumer mattress. There is a weight limit of 330 pounds (150 kg) when properly
sized to the bed mattress, and areas of the individual that require skin/soft tissue protection must be supported by SOFFLEX 2.
Compatibility: The SOFFLEX 2 should not be used with the ROHO Leveling Pad or the ROHO Mattress Overlay Foam Insert Pad.
An experienced clinician should determine whether the product is appropriate for the individual's particular equipment needs. The product's intended use
statement alone should not be relied upon to make that determination.
The medical products featured in this document are intended to be only one part of an overall care regimen that includes all therapeutic equipment and
interventions. An experienced clinician should identify this care regimen after evaluating the individual's physical needs and overall medical condition.
A clinician should also evaluate for visual, reading, and cognitive impairment to determine the need for caregiver assistance or the need for other assistive
technology, such as large-print instructions, to ensure proper product use.

Important Safety Information

Warnings:
- The product should be set up by the equipment provider or clinician.
- While the product is in use, continue to follow all clinician
recommendations for skin protection, including any schedule for regularly
repositioning the individual.
- The support surface products featured in this manual will function without
side rails; however, side rails may be necessary for some individuals.
The decision whether to use side rails should be made by the individual's
clinician and/or healthcare provider. If side rails are necessary for an
individual, the following points should be considered by the individual in
conjunction with his/her clinician or healthcare provider to reduce the risk
of falling or entrapment.
- If it has been determined that side rails are clinically indicated for an
individual, knowledgeable and properly trained caregivers should
identify and minimize any risks of entrapment in side rails.
- If it has been determined that side rails are NOT clinically indicated for
an individual, knowledgeable and properly trained caregivers should
identify and minimize any risks of falling out of bed.
- Whether side rails are used or not used, knowledgeable and properly
trained caregivers should assess the need for devices or aids that will
reduce the risk of falling out of bed or entrapment in side rails.
- The overlay MUST be correctly sized to the bed mattress and to the
individual.
- If the overlay is NOT correctly sized to the bed mattress and the
individual, the product's benefits may be reduced or eliminated,
increasing risk to skin and other soft tissue.
- If a bed mattress is too wide, the straps provided to secure the
SOFFLEX 2 to the bed mattress may not fit as intended. If straps are
not used as instructed for the SOFFLEX 2, the product may slip or
slide, and the individual may be vulnerable to falling.
- Skin/soft tissue breakdown can occur due to a number of factors,
which vary by individual. Check skin frequently, at least once a day.
Redness, bruising, or darker areas (when compared to normal skin)
may indicate superficial or deep tissue injury and should be addressed.
If there is any discoloration to skin/soft tissue, STOP USE immediately.
If the discoloration does not disappear within 30 minutes after disuse,
immediately consult a clinician.
- The cushioning products featured in this operation manual may introduce
radiopacities and are therefore NOT recommended for use with x-rays.
Radiopacities may interfere with diagnoses or surgical procedures that
require radiographic images.
ROHO SOFFLEX 2 Mattress Overlay Operation Manual
Warnings:
- DO NOT use the product as a water flotation device (e.g., a Life Preserver).
It will NOT support you in water.
- If you are unable to perform any tasks described in this manual, seek
assistance by contacting your clinician, equipment provider, distributor, or

Customer Support.

- DO NOT expose the product to high heat, open flames or hot ashes. Testing
or certification claims, including for flammability, may no longer apply to this
device when it is combined with other products or materials. Check testing
and certification claims for all products used in combination with this device.
- DO NOT use the product as a transfer surface. DO NOT reposition the
product while it is in use.
- The mattress overlay surface will acclimate to the surrounding temperature.
Take appropriate precautions, especially when the overlay will contact
unprotected skin.
- The SOFFLEX 2 should not be used by infants or other individuals who are
at risk of suffocation.
Cautions:
- Periodically, check the cover and components for damage and replace if
necessary.
- DO NOT use a pump, cover or repair kit other than those compatible with the
product.
- Changes in altitude may require adjustment to the product.
- Keep the product away from sharp objects.
- If a product has been in temperatures less than 32°F / 0°C and exhibits
unusual stiffness, allow the product to warm to room temperature, then open
air valve(s). Roll and unroll the product until the material is soft and pliable
again. Repeat Hand Check/Adjustment instructions before using.
- DO NOT use any valve or air cell as a handle for carrying or pulling the
product. Grasp the product by the base or the outside edges.
Important Notes:
- An unoccupied product may appear to be underinflated (not enough air)
even if it has been inflated and correctly adjusted for a specific individual.
This is because the individual's body mass is not pushing down on the air
cells.
- CPR may be performed without deflating the product. A cardiac board is not
necessary.
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